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23.4.2013 Official
Journal
of
the
European
Union L
111/39
COMMISSION IMPLEMENTING REGULATION (EU) No 369/2013
of 22 April 2013
approving the active substance potassium phosphonates, in accordance with Regulation (EC) No
1107/2009 of the European Parliament and of the Council concerning the placing of plant
protection products on the market, and amending the Annex to Commission Implementing
Regulation (EU) No 540/2011
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Standing Committee on the Food Chain and Animal
Health and the draft assessment report was finalised on
Having regard to the Treaty on the Functioning of the European
15 March 2013 in the format of the Commission review
Union,
report for potassium phosphonates.
Having regard to Regulation (EC) No 1107/2009 of the
(5)
It has appeared from the various examinations made that
European Parliament and of the Council of 21 October 2009
plant protection products containing potassium phos
concerning the placing of plant protection products on the
phonates may be expected to satisfy, in general, the
market and repealing Council Directives 79/117/EEC and
requirements laid down in Article 5(1)(a) and (b) and
91/414/EEC ( 1 ), and in particular Articles 13(2) and 78(2)
Article 5(3) of Directive 91/414/EEC, in particular with
thereof,
regard to the uses which were examined and detailed in
the Commission review report. It is therefore appropriate
Whereas:
to approve potassium phosphonates.
(1) In
accordance
with
Article
80(1)(a)
of
Regulation
(EC)
No (6) In
accordance
with
Article
13(2)
of
Regulation
(EC)
No
1107/2009, Council Directive 91/414/EEC (
1107/2009 in conjunction with Article 6 thereof and in

2 ) is to apply,
with respect to the procedure and the conditions for
the light of current scientific and technical knowledge, it
approval, to active substances for which a decision has
is, however, necessary to include certain conditions and
been adopted in accordance with Article 6(3) of that
restrictions. It is, in particular, appropriate to require
Directive before 14 June 2011. For potassium phos
further confirmatory information.
phonates (initially referred to as ‘potassium phosphite’)
the conditions of Article 80(1)(a) of Regulation (EC) No
(7) A
reasonable
period
should
be
allowed
to
elapse
before
1107/2009 are fulfilled by Commission Decision
approval in order to permit Member States and the
2003/636/EC (
interested parties to prepare themselves to meet the

3 ).
new requirements resulting from the approval.
(2) In
accordance
with
Article
6(2)
of
Directive
91/414/EEC,
France received on 22 August 2002 an application from
(8) Without
prejudice
to
the
obligations
provided
for
in
Luxembourg Industries (Pamol) Ltd for the inclusion of
Regulation (EC) No 1107/2009 as a consequence of
the active substance potassium phosphonates in Annex I
approval, taking into account the specific situation
to Directive 91/414/EEC. Decision 2003/636/EC
created by the transition from Directive 91/414/EEC to
confirmed that the dossier was ‘complete’ in the sense
Regulation (EC) No 1107/2009, the following should,
that it could be considered as satisfying, in principle, the
however, apply. Member States should be allowed a
data and information requirements of Annexes II and III
period of six months after approval to review authori
to Directive 91/414/EEC.
sations of plant protection products containing

potassium phosphonates. Member States should, as
appropriate, vary, replace or withdraw authorisations.
(3) For
that
active
substance,
the
effects
on
human
and
animal health and the environment have been assessed,
By way of derogation from that deadline, a longer
in accordance with the provisions of Article 6(2) and (4)
period should be provided for the submission and
of Directive 91/414/EEC, for the uses proposed by the
assessment of the update of the complete Annex III
applicant. The designated rapporteur Member State
dossier, as set out in Directive 91/414/EEC, of each
submitted a draft assessment report on 1 February 2005.
plant protection product for each intended use in

accordance with the uniform principles.
(4) The
draft
assessment
report
was
reviewed
by
the
Member (9) The
experience
gained
from
inclusions
in
Annex
I
to
States and the European Food Safety Authority (here
Directive 91/414/EEC of active substances assessed in
inafter ‘the Authority’). The Authority presented to the
the framework of Commission Regulation (EEC) No
Commission its conclusion on the review of the pesticide
3600/92 of 11 December 1992 laying down the
risk assessment of the active substance potassium phos
detailed rules for the implementation of the first stage
phonates ( 4 ) on 16 December 2011. The draft assessment
of the programme of work referred to in Article 8(2) of
report and the conclusion of the Authority were reviewed
Council Directive 91/414/EEC concerning the placing of
by the Member States and the Commission within the
plant protection products on the market ( 5 ) has shown
that difficulties can arise in interpreting the duties of
( 1 ) OJ L 309, 24.11.2009, p. 1.
holders of existing authorisations in relation to access
( 2 ) OJ L 230, 19.8.1991, p. 1.
to data. In order to avoid further difficulties it therefore
( 3 ) OJ L 221, 4.9.2003, p. 42.
( 4 ) EFSA Journal 2012; 10(12):2963. Available online: www.efsa.
europa.eu
( 5 ) OJ L 366, 15.12.1992, p. 10.

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L 111/40
EN
Official Journal of the European Union
23.4.2013
appears necessary to clarify the duties of the Member
2. By
way
of
derogation
from
paragraph
1,
for
each
auth
States, especially the duty to verify that the holder of
orised plant protection product containing potassium phos
an authorisation demonstrates access to a dossier
phonates as either the only active substance or as one of
satisfying the requirements of Annex II to that Directive.
several active substances, all of which were listed in the
However, this clarification does not impose any new
Annex to Implementing Regulation (EU) No 540/2011 by
obligations on Member States or holders of authori
30 September 2013 at the latest, Member States shall re-
sations compared to the Directives which have been
evaluate the product in accordance with the uniform principles,
adopted until now amending Annex I to that Directive
as referred to in Article 29(6) of Regulation (EC) No
or the Regulations approving active substances.
1107/2009, on the basis of a dossier satisfying the requirements
of Annex III to Directive 91/414/EEC and taking into account
(10) In
accordance
with
Article
13(4)
of
Regulation
(EC)
No
the column on specific provisions of Annex I to this Regulation.
1107/2009, the Annex to Commission Implementing
On the basis of that evaluation, they shall determine whether
Regulation (EU) No 540/2011 of 25 May 2011 imple
the product satisfies the conditions set out in Article 29(1) of
menting Regulation (EC) No 1107/2009 of the European
Regulation (EC) No 1107/2009.
Parliament and of the Council as regards the list of
approved active substances
( 1 ) should be amended
Following that determination Member States shall:
accordingly.
(11) The
measures
provided
for
in
this
Regulation
are
in
(a) in the case of a product containing potassium phosphonates
accordance with the opinion of the Standing
as the only active substance, where necessary, amend or
Committee on the Food Chain and Animal Health,
withdraw the authorisation by 31 March 2015 at the
latest; or
HAS ADOPTED THIS REGULATION:
(b) in the case of a product containing potassium phosphonates
Article 1
as one of several active substances, where necessary, amend
Approval of active substance
or withdraw the authorisation by 31 March 2015 or by the
date fixed for such an amendment or withdrawal in the
The active substance potassium phosphonates, as specified in
respective act or acts which added the relevant substance
Annex I, is approved subject to the conditions laid down in that
or substances to Annex I to Directive 91/414/EEC or
Annex.
approved that substance or those substances, whichever is
Article 2
the latest.
Re-evaluation of plant protection products
Article 3
1. Member
States
shall
in
accordance
with
Regulation
(EC)
Amendments to Implementing Regulation (EU) No
No 1107/2009, where necessary, amend or withdraw existing
540/2011
authorisations for plant protection products containing
potassium phosphonates as an active substance by 31 March
The Annex to Implementing Regulation (EU) No 540/2011 is
2014.
amended in accordance with Annex II to this Regulation.
By that date they shall in particular verify that the conditions in
Article 4
Annex I to this Regulation are met, with the exception of those
identified in the column on specific provisions of that Annex,
Entry into force and date of application
and that the holder of the authorisation has, or has access to, a
This Regulation shall enter into force on the twentieth day
dossier satisfying the requirements of Annex II to Directive
following that of its publication in the Official Journal of the
91/414/EEC in accordance with the conditions of Article 13(1)
European Union.
to (4) of that Directive and Article 62 of Regulation (EC) No
1107/2009.
It shall apply from 1 October 2013.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 22 April 2013.
For the Commission
The President
José Manuel BARROSO
( 1 ) OJ L 153, 11.6.2011, p. 1.

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23.4.2013 Off
ANNEX I
Common Name,
Identification Numbers
IUPAC Name Purity
(1 ) Date
of
approval Expiration
of
approval Specific
provisions
Potassium phosphonates
Potassium hydrogen
31,6 to 32,6 %
1 October 2013 30
September
2023
For the implementation of the uniform principles as referred to in
(no ISO name)
phosphonate,
phosphonate ions (sum
Article 29(6) of Regulation (EC) No 1107/2009, the conclusions
EN
of hydrogen phosphonate
of the review report on potassium phosphonates, and in

CAS No
Dipotassium phosphonate and phosphonate ions)
particular Appendices I and II thereof, as finalised in the
Standing Committee on the Food Chain and Animal Health on
13977-65-6 for potassium
17,8 to 20,0 % potassium
15 March 2013, shall be taken into account.
hydrogen phosphonate
≥ 990 g/kg on dry weight
In this overall assessment Member States shall pay particular
13492-26-7 for
basis
attention to:
dipotassium phosphonate
— the risk to birds and mammals,
Mixture: none
— the risk of eutrophication of surface water, if the substance is
CIPAC No 756 (for
applied in regions or under conditions favouring a quick
potassium phosphonates)
icial
oxidation of the active substance in surface water.
Jour
Conditions of use shall include risk mitigation measures, where
appropriate.
nal
The applicant shall submit confirmatory information as regards
of
the long-term risk to insectivorous birds.
the
European
The applicant shall submit to the Commission, the Member States
and the Authority that information by 30 September 2015.
(1 ) Further details on identity and specification of active substance are provided in the review report.
Union
L
111/41

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L 111/42
ANNEX II
In Part B of the Annex to Implementing Regulation (EU) No 540/2011, the following entry is added:
Number Common
Name,
Identification
Numbers IUPAC
Name Purity
(*) Date
of
approval Expiration
of
approval Specific
provisions
‘40 Potassium
phosphonates
(no
ISO
Potassium hydrogen phosphonate, 31,6 to 32,6 % phosphonate 1 October 2013 30
September
2023 For the implementation of the uniform prin
EN
name)
ions (sum of hydrogen phos
ciples as referred to in Article 29(6) of

Dipotassium phosphonate
phonate and phosphonate ions)
Regulation (EC) No 1107/2009, the
CAS No
conclusions of the review report on
17,8 to 20,0 % potassium
13977-65-6 for potassium hydrogen
potassium phosphonates, and in particular
phosphonate
≥ 990 g/kg on dry weight basis
Appendices I and II thereof, as finalised in
the Standing Committee on the Food Chain
13492-26-7 for dipotassium phos
and Animal Health on 15 March 2013, shall
phonate
be taken into account.
Mixture: none
In this overall assessment Member States
shall pay particular attention to:
CIPAC No 756 (for potassium phos
Off
phonates)
— the risk to birds and mammals,
icial
— the risk of eutrophication of surface
Jour
water, if the substance is applied in
regions or under conditions favouring a
nal
quick oxidation of the active substance
of
in surface water.
the
Conditions of use shall include risk miti
European
gation measures, where appropriate.
The applicant shall submit confirmatory
information as regards the long-term risk
Union
to insectivorous birds.
The applicant shall submit to the
Commission, the Member States and the
Authority that information by 30 September
2015.’
(*) Further details on identity and specification of active substance are provided in the review report.
23.4.2013

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